NCT00006164

Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment

Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,050 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months. Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits. The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial. The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.

Conditions

• Chronic Hepatitis c
• Cirrhosis, Liver
• Fibrosis, Liver
• Hepatic Cirrhosis

Interventions

Type	Name	Description
DRUG	Peginterferon alfa-2a + Ribavirin	Peginterferon alfa-2a 180 mcg/week injection, for 24 weeks, plus 1000-1200 mg Ribavirin oral (prescribed according to weight \<75 kg, \>75 kg) daily in two divided doses for 24 weeks
DRUG	Peginterferon alfa-2a	90 mcg/week injection, for 3.5 years

Timeline

• Start date: 2000-06-01
• Primary completion: 2007-04-01
• Completion: 2009-10-01
• First posted: 2000-08-09
• Last updated: 2020-05-12
• Results posted: 2009-09-04

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study